NCT05767060

BAT7104 Injection in Patients With Advanced Malignant Tumors.

A Multi-center, Open Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Clinical Efficacy of BAT7104 Injection in Patients With Advanced Malignant Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, open phase Ia/Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors.

Detailed description

This is a multi-center, open, dose-increased and dose-expanded phase I clinical study. About 18-42 patients will be recruited from research centers in China. In the stage of dose increase, the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors were investigated by using accelerated titration and "3+3" dose increase design. During the dose increase test, the appropriate dose was selected according to the previous study data of the extended study.

Conditions

• Advanced Malignant Tumor

Interventions

Type	Name	Description
DRUG	BAT7104 injection	According to the protocol, each dose group is given intravenous infusion at the rate of mg/kg, and the recommended infusion time is ≥ 60 minutes. Once every two weeks (Q2W), on the first day of each cycle.

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-12-11
• Completion: 2024-12-11
• First posted: 2023-03-14
• Last updated: 2025-12-02

Locations

1 site across 1 country: China